Senior Vice President – Regulatory Affairs and Quality

Verastem Oncology

. Provide enterprise-wide leadership for global regulatory strategy and product quality .

Posted 10/6/2026full-timeBoston • Massachusetts • United StatesSenior💰 $365,000 - $421,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global regulatory strategy and product quality oversight, with a strong focus on compliance with GxP and GMP principles. Proven ability to lead cross-functional teams and drive successful regulatory submissions and product lifecycle management.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentGxP and GMP ComplianceRegulatory Submissions LeadershipCross-Functional Team LeadershipStakeholder Management and Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsProduct Quality OversightHealth Authority InteractionsQuality Systems ManagementCombination Product ExperienceRegulatory IntelligenceClinical Development OversightCMC KnowledgeSubmission PreparationInspection Readiness

Soft Skills

Team BuildingCollaborationInfluencing SkillsNegotiation SkillsBusiness Judgment

Industry Keywords

Biopharmaceutical SectorProduct Lifecycle ManagementInternational RegulationsEmerging Quality ExpectationsContract Manufacturing Oversight

About the role

Key responsibilities & impact

Provide enterprise-wide leadership for global regulatory strategy and product quality
Define and execute an integrated vision supporting development, approval, commercialization, and compliant lifecycle management of Verastem's small molecule portfolio
Oversee global regulatory activities, primarily in the United States, European Union, and Japan
Lead strategic, tactical, and operational product quality oversight across the portfolio
Develop and implement global regulatory strategies for efficient development, submission, approval, commercialization, and lifecycle management
Lead regulatory strategies across clinical development, CMC, safety, and other product lifecycle activities
Oversee preparation, review, and delivery of global regulatory submissions and responses to health authority questions and commitments
Improve regulatory infrastructure and processes, including support for simultaneous or closely sequenced submissions
Ensure regulatory activities, processes, and submissions comply with applicable laws, standards, guidelines, and commitments
Provide oversight for regulatory intelligence, promotional and non-promotional material review, and regulatory support for market access and business conduct activities
Lead global quality strategy for Verastem's small molecule portfolio
Ensure quality activities align with company policies and applicable GxP and GMP requirements
Support internal audits and certifications and oversee external audits of contract manufacturing organizations and other business partners
Establish and maintain inspection readiness across the organization
Guide quality strategy for combination products and incorporate emerging products, technologies, including AI, and regulatory expectations into portfolio plans
Build cross-functional partnerships across Regulatory Affairs, Quality, Clinical Development, Clinical Operations, Safety, Pharmacovigilance, Manufacturing, and other functions
Interpret international regulations and emerging quality expectations and lead cross-functional action
Represent Verastem with health authorities, industry groups, external forums, and other stakeholders
Partner with industry leaders on policy and technical issues affecting the biopharmaceutical sector

Requirements

What you’ll need

Bachelor's degree in a scientific, technical, or other relevant field required
At least 20 years of progressively responsible experience in Regulatory Affairs, Quality, or closely related biopharmaceutical functions, including significant senior leadership experience
Demonstrated success developing and executing global regulatory strategies across the product lifecycle, with substantial experience in the United States and working knowledge of European Union, Japanese, ICH, and other international requirements
Deep knowledge of GxP and GMP principles and experience providing product quality oversight for small molecule products across development and commercial stages
Experience leading major regulatory submissions, health authority interactions, product specification strategies, and post-approval commitments
Working knowledge of quality systems, product quality review and trending, external manufacturing oversight, audits, and inspection readiness
Combination product or device experience is an advantage
Proven ability to build, inspire, and retain high-performing, diverse teams and to develop leaders in a fast-paced, evolving environment
Experience building a culture of urgency, collaboration and quality
Strong business judgment and ability to translate complex regulatory and quality requirements into practical, risk-based strategies and clear organizational priorities
Exceptional written and verbal communication, stakeholder management, influencing, and negotiation skills
Demonstrated ability to contribute as a company executive, improve cross-functional effectiveness, lead change, and drive corporate success